Urinary ContinenceNCT07551674
Effects of Action Observation and Metaphorical Imagery in Pelvic Floor Muscle Training for Geriatric Urinary Incontinence
A study testing Pelvic Floor Muscle Training program and Pelvic Floor Muscle Training via Action Observation Therapy in people with Urinary Continence, run by Fenerbahce University at 1 site in Turkey (Türkiye).
Trial summary
This clinical trial investigates the effects of a 12-week Pelvic Floor Muscle Training (PFMT) program applied via Action Observation Therapy (AOT) with metaphorical imagery on urinary incontinence, quality of life, and treatment adherence in geriatric women. Read more about this study
- Who is it for?
- Ages 65 to 80 years, women only
- Conditions the study is for
- Urinary Continence
- What is being tested?
- Pelvic Floor Muscle Training program and Pelvic Floor Muscle Training via Action Observation Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 19 Mar 2025to 1 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 80 years
- Women only
- No healthy volunteers
- Older adult
Who may be able to join
- Diagnosed with stress or stress-predominant mixed urinary incontinence by a physician
- Women aged 65 years and older
- Literate in Turkish to understand, interpret, and answer the questionnaires
- Scoring 24 or higher on the Mini-Mental State Examination (MMSE)
- Able to walk independently without the use of any walking aids (assistive devices)
- Having signed the informed consent form
Who cannot join
- Received pelvic floor muscle training within the past 6 months
- Presence of fecal incontinence
- Current genitourinary infection or use of medication for urinary incontinence
- History of urinary incontinence surgery or presence of symptomatic pelvic organ prolapse
- Presence of neurological, orthopedic, psychiatric, hematological, or cardiovascular conditions that would preclude participation in exercise
- Body mass index (BMI) ≥ 25 kg/m²
- Hearing or visual impairments that would negatively affect participation
- Presence of hematuria, urethral and/or bladder fistula, or a history of pelvic surgery
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Fenerbahce University Department of Physiotherapy and Rehabilitation
Istanbul, 34758
ARZU ÖZDİNÇLER, PROF, +90 216 910 1907, arzu.ozdincler@fbu.edu.tr
About this study
Official title: Investigation of the Effects of Pelvic Floor Muscle Training Applied Via Action Observation Method Accompanied by Metaphorical Imagery on Urinary Incontinence in Geriatric Women
This clinical trial investigates the effects of a 12-week Pelvic Floor Muscle Training (PFMT) program applied via Action Observation Therapy (AOT) with metaphorical imagery on urinary incontinence, quality of life, and treatment adherence in geriatric women. The study will be conducted between June 2025 and June 2026 in nursing homes in Istanbul, targeting women aged 65 and older who are diagnosed with stress or stress-predominant mixed urinary incontinence, possess normal cognitive function (Standardized Mini Mental Test score ≥ 24), and walk independently. Eligible participants will be divided into groups, where both will undergo a progressive exercise regimen involving twice-weekly 45-50 minute group sessions that advance from supine positions to standing and jumping movements. However, the AOT study group will uniquely perform these exercises while observing and imagining projected metaphor-themed visuals to enhance motor learning and motivation. Efficacy will be evaluated pre- and post-intervention using various standardized tools, including the Pelvic Floor Distress Inventory-20, a 24-hour pad test, the Incontinence Severity Index, the Movement Imagery Questionnaire-3, and the Incontinence Quality of Life Scale, to comprehensively assess improvements in incontinence severity, functional status, and overall well-being.
- Conditions
- Urinary Continence
- Being tested
- Pelvic Floor Muscle Training program, Pelvic Floor Muscle Training via Action Observation Therapy
- Keywords
- urinary incontinence, geriatrics, action observation
- Medical subject headings
- Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pelvic Floor Muscle Training programOther
Participants will engage in a 12-week Pelvic Floor Muscle Training (PFMT) program. The exercises will be conducted twice a week in group sessions lasting 45-50 minutes each. These sessions will be supervised by a physiotherapist and performed in small groups of five participants.
Pelvic Floor Muscle Training via Action Observation TherapyOther
Participants will be enrolled in a Pelvic Floor Muscle Training (PFMT) program using the action observation method accompanied by metaphorical imagery. This program will be administered over 12 weeks, consisting of twice-weekly group sessions lasting 45-50 minutes each. The exercise content is identical for both groups. However, during the sessions for this specific group, metaphor-themed visuals will be projected onto a screen, and participants will be given the instruction: 'Perform the movement by imagining it as shown in the visual.' To enhance physical participation and motivation, verbal cues and positive reinforcement will be provided by the physiotherapist. The exercises and the corresponding metaphors will be updated on a weekly basis. All sessions will be supervised by a physiotherapist in small groups of five participants.
| Study group | Role | What they receive |
|---|---|---|
| Pelvic Floor Muscle Training program | Experimental | Exercise Receives: Other: Pelvic Floor Muscle Training program |
| Pelvic Floor Muscle Training via Action Observation Therapy | Experimental | Exercise with AOT Receives: Other: Pelvic Floor Muscle Training via Action Observation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mini-Mental State Examination
Measured: Baseline and after 12-weeks
Pelvic Floor Distress Inventory
Measured: Baseline and after 12-weeks
The Incontinence Severity Index
Measured: Baseline and after 12-weeks
Movement Imagery Questionnaire-3
Measured: Baseline and after 12-weeks
Secondary outcomes (2)
Geriatric Self-Efficacy Index for Urinary Incontinence
Measured: Baseline and after 12-weeks
Incontinence Quality of Life Questionnaire
Measured: Baseline and after 12-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2026
- Study start19 Mar 2025
- Primary completion27 Jul 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary ContinenceStudies of the same condition, open and under way.
- More trials run by Fenerbahce UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fenerbahce University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arzu Razak Ozdinçler, Fenerbahce University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07551674
- Sponsor's protocol ID
- 1002-GERIATRICS-UI
- Status last verified
- May 2026
- First submitted
- 20 Apr 2026
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared upon reasonable request to the principal investigator/corresponding author for the purpose of meta-analysis or related academic research.
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effects of Pelvic Floor Muscle Training Applied Via Action Observation Method Accompanied by Metaphorical Imagery on Urinary Incontinence in Geriatric Women
- ClinicalTrials.gov ID
- NCT07551674
- Acronym / sponsor ID
- 1002-GERIATRICS-UI
- Conditions
- Urinary Continence
- Keywords
- urinary incontinence, geriatrics, action observation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Fenerbahce UniversityUniversity, hospital or other
- Study start
- 19 Mar 2025 (actual)
- Primary completion
- 27 Jul 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 27 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical trial investigates the effects of a 12-week Pelvic Floor Muscle Training (PFMT) program applied via Action Observation Therapy (AOT) with metaphorical imagery on urinary incontinence, quality of life, and treatment adherence in geriatric women. The study will be conducted between June 2025 and June 2026 in nursing homes in Istanbul, targeting women aged 65 and older who are diagnosed with stress or stress-predominant mixed urinary incontinence, possess normal cognitive function (Standardized Mini Mental Test score ≥ 24), and walk independently. Eligible participants will be divided into groups, where both will undergo a progressive exercise regimen involving twice-weekly 45-50 minute group sessions that advance from supine positions to standing and jumping movements. However, the AOT study group will uniquely perform these exercises while observing and imagining projected metaphor-themed visuals to enhance motor learning and motivation. Efficacy will be evaluated pre- and post-intervention using various standardized tools, including the Pelvic Floor Distress Inventory-20, a 24-hour pad test, the Incontinence Severity Index, the Movement Imagery Questionnaire-3, and the Incontinence Quality of Life Scale, to comprehensively assess improvements in incontinence severity, functional status, and overall well-being.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pelvic Floor Muscle Training program | Experimental | Other: Pelvic Floor Muscle Training programExercise |
| Pelvic Floor Muscle Training via Action Observation Therapy | Experimental | Other: Pelvic Floor Muscle Training via Action Observation TherapyExercise with AOT |
Who may qualify
- Ages
- 65 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- Diagnosed with stress or stress-predominant mixed urinary incontinence by a physician
- Women aged 65 years and older
- Literate in Turkish to understand, interpret, and answer the questionnaires
- Scoring 24 or higher on the Mini-Mental State Examination (MMSE)
- Able to walk independently without the use of any walking aids (assistive devices)
Key exclusion criteria (8 listed)
- Received pelvic floor muscle training within the past 6 months
- Presence of fecal incontinence
- Current genitourinary infection or use of medication for urinary incontinence
- History of urinary incontinence surgery or presence of symptomatic pelvic organ prolapse
- Presence of neurological, orthopedic, psychiatric, hematological, or cardiovascular conditions that would preclude participation in exercise
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pelvic Floor Muscle Training programParticipants will engage in a 12-week Pelvic Floor Muscle Training (PFMT) program. The exercises will be conducted twice a week in group sessions lasting 45-50 minutes each. These sessions will be supervised by a physiotherapist and performed in small groups of five participants. | Other | Pelvic Floor Muscle Training program |
| Pelvic Floor Muscle Training via Action Observation TherapyParticipants will be enrolled in a Pelvic Floor Muscle Training (PFMT) program using the action observation method accompanied by metaphorical imagery. This program will be administered over 12 weeks, consisting of twice-weekly group sessions lasting 45-50 minutes each. The exercise content is identical for both groups. However, during the sessions for this specific group, metaphor-themed visuals will be projected onto a screen, and participants will be given the instruction: 'Perform the movement by imagining it as shown in the visual.' To enhance physical participation and motivation, verbal cues and positive reinforcement will be provided by the physiotherapist. The exercises and the corresponding metaphors will be updated on a weekly basis. All sessions will be supervised by a physiotherapist in small groups of five participants. | Other | Pelvic Floor Muscle Training via Action Observation Therapy |
Primary outcome
Mini-Mental State Examination
Time frame: Baseline and after 12-weeks
Pelvic Floor Distress Inventory
Time frame: Baseline and after 12-weeks
The Incontinence Severity Index
Time frame: Baseline and after 12-weeks
Movement Imagery Questionnaire-3
Time frame: Baseline and after 12-weeks
2 secondary outcomes
Geriatric Self-Efficacy Index for Urinary Incontinence
Time frame: Baseline and after 12-weeks
Incontinence Quality of Life Questionnaire
Time frame: Baseline and after 12-weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
- Individual participant dataSharing planned: Yes. Data will be shared upon reasonable request to the principal investigator/corresponding author for the purpose of meta-analysis or related academic research.
Related trials for Urinary Continence
Active, not recruiting
EVALUATION OF THE SAFETY AND EFFICACY OF ADJUSTABLE CONTINENCE THERAPY BALLOONS IN BLADDER EXSTROPHY AND INCONTINENT EPISPADIAS PATIENTS
Bladder Exstrophy
Not yet recruiting
Anterior Bridge-Preserving Versus Conventional Early Apical Release in Bipolar Enucleation of the Prostate
Benign Prostatic Hyperplasia, Benign Prostatic Obstruction
Recruiting
Adjustable Continence Therapy (ACT) for the Treatment of Female SUI
Urinary Incontinence, Urinary Incontinence,Stress
Recruiting
ProACT Post-Approval Study
Stress Urinary Incontinence
RecruitingObservational study
Post Market Clinical Follow-up Study on TVT ABBREVO® Continence System
Stress Urinary Incontinence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pelvic Floor Muscle Training program and Pelvic Floor Muscle Training via Action Observation Therapy in people with Urinary Continence, run by Fenerbahce University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ARZU ÖZDİNÇLER, Prof (+90 216 910 1907, arzu.ozdincler@fbu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mini-Mental State Examination (time frame: Baseline and after 12-weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2026.